Type I diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female aged 6-65 years (both inclusive) • Type 1 diabetes mellitus (as diagnosed clinically) = 12 months • Body mass index for children: 15.0-20.0 kg/m² (both inclusive), for adolescents: 18.0-28.0 kg/m² (both inclusive) and for adults = 30.0 kg/m² Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening • Not able or willing to refrain from smoking during the inpatient period • Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetic total exposure of SIBA in children, adolescents and adult subjects with type 1 diabetes;Secondary Objective: • To compare the pharmacokinetic properties of SIBA between the three different age groups • To compare the effects of age on SIBA pharmacokinetic properties with the effects of age on insulin glargine pharmacokinetic properties • To assess the safety and tolerability of SIBA in children, adolescents and adult subjects with type 1 diabetes ;Primary end point(s): • AUC_I454,0-8,SD, area under the serum insulin 454 concentration-time curve from 0 to infinity after single-dose | — |
Countries
Germany
Outcome results
None listed